The U.S. Meals and Drug Administration authorized Blenrep (belantamab mafodotin-blmf) together with bortezomib and dexamethasone for the therapy of grownup sufferers with relapsed or refractory a number of myeloma.
The approval is for sufferers who’ve obtained at the very least two prior traces of remedy, together with a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent.
Outcomes from the pivotal DREAMM-7 part 3 trial knowledgeable the approval. In sufferers who had two or extra prior traces of remedy, together with a PI and an IMID, in contrast with a daratumumab-based triplet remedy, Blenrep together confirmed a clinically significant discount within the threat for loss of life (hazard ratio [HR], 0.49) and a tripled median progression-free survival (31.3 months versus 10.4 months; HR, 0.31). No new security or tolerability indicators had been seen.
“There is an urgent need for new and novel therapies, as nearly all patients with multiple myeloma experience relapse, and retreating with the same mechanism of action often leads to suboptimal outcomes,” Tony Wooden, chief scientific officer at GSK, mentioned in an announcement. “As the only anti-B-cell maturation antigen agent that can be administered across health care settings, including in community centers where 70% of patients receive care, Blenrep fulfills a major patient need.”
Approval of Blenrep was granted to GSK.
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FDA approves Blenrep for relapsed or refractory a number of myeloma (2025, October 30)
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